FDA Device

Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software

Hazard

Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.

What You Should Do

Remedy

A recall letter, sent to the consignees on June 23, stated that the firm would telephone the consignees to arrange the correction of their affected pumps by reprogramming with the new software.

Products

Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
Brand
Deltec, Inc
UPC
Pump Serial numbers 658825, 658837, 658840, 658842, 658844 - 658865, 658867, 658869 - 658896, 658898 - 658918, 658920 - 658936, 658941, 658943 - 658947, 658949, 662473 - 662477, 662483, 662485, 662488 - 662490, and 662635 - 662659

Units Affected

135 pumps